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Phase 1/2 Study of KSQ-004EX for Advanced Solid Tumors

This study is testing a new treatment called KSQ-004EX for people with certain advanced solid tumors, including melanoma, lung, head and neck, colorectal, pancreatic, and cervical cancers. KSQ-004EX is made from your own immune cells (tumor infiltrating lymphocytes) that are specially engineered. Researchers want to find the safest and most effective dose of KSQ-004EX (Phase 1) and then see how well it works to control the cancer (Phase 2). You would also receive other medications like Cyclophosphamide, Fludarabine, and Interleukin-2. The main goal is to check for safety and any side effects. To join, you must be at least 18 years old and have specific types of advanced cancer that have progressed after prior treatments.

Study design
This is a Phase 1/2 interventional study with a planned enrollment of 141 participants. Phase 1 will determine the recommended dose, and Phase 2 will evaluate its effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06598371

A Phase 1/2 Study of KSQ-004EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate Genes Encoding SOCS1 and Regnase-1, in Patients With Select Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~141 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:CyclophosphamideFludarabineKSQ-004EXInterleukin-2

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Select Advanced Solid Tumors

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Cervical CarcinomaColorectal AdenocarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaMelanomaPancreatic Ductal AdenocarcinomaSolid Neoplasm

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Rodabe N Amaria, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Rodabe N Amaria, MD
[email protected]
713-792-2921
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Any therapy/regimen discontinued due to intolerance/tolerability issues
Retreatment with the same class or previous class of treatment alone or in combination c. Locally advanced recurrent and/or metastatic histologically and/or cytologically confirmed HNSCC that has been previously treated with at least 1 and no more than 4 lines of prior therapy in the advanced/metastatic setting.

What this trial measures

  • Safety and adverse events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0